510(k) K243878
K243878 is an FDA 510(k) premarket notification submitted by Carl Zeiss Meditec, Inc. for the device "CLARUS (700)". The FDA issued a decision of Substantially Equivalent on April 17, 2025. The device falls under product code QER (Camera, Ophthalmic, Slit-Scanning), a Class II device regulated under 21 CFR 886.1120. Carl Zeiss Meditec, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 17, 2025
- Date Received
- December 18, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Camera, Ophthalmic, Slit-Scanning
- Device Class
- Class II
- Regulation Number
- 886.1120
- Review Panel
- OP
- Submission Type
An ophthalmic slit-scanning camera is an AC-powered device intended to take photographs of the eye and the surrounding area.